Kornimate/medical-research-clean huggingface dataset:
colchicine for reduction of periprocedural myocardial injury in percutaneous coronary intervention

Conditions: Periprocedural Myocardial Infarction; Periprocedural Myocardial Injury

Summary: study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective pci and its role in reduction of maces.

prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective pci at cardiology unit, imd, sohag university hospital, these two groups are: 1. group of patients received oral tablet colchicine 6-24 hours before pci loading dose 1 mg followed by 500 mcg after one hour. n.b. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. treatment of side effects symptomatic treatment ( antiemetic, etc.) 2. control group of patients. number of patients according to sample size equation. sample size equation is used to calculate the minimum size of the required sample: n = (z)2 p (1- p) / d2 * number of patients according to sample size equation about 300 patients 150 patient in each group of study. * estimated study duration 2 years. * n.b. randomization method: first patient prepared to pci will be included in colchicine group second patient will be included in control group and so on.

Eligibility criteria:
inclusion criteria: 1. elective pci in acs patients with cardiac troponin peaked and stabilized and ccs patients . 2. pp myocardial injury (any increase in post-pci troponin if pre-pci troponin is negative or rise in post-pci troponin above baseline pre-pci troponin when it is peaked and stabilized). 3. ppmi (rise in post-pci troponin plus new evidence of ischemia). exclusion criteria: 1. patients with active infections. 2. patients taking anti-inflammatory medications. 3. patients presented with acs( still rising troponin). 4. severe renal impairment ( creatinine clearance \< 45 ml/min ). 5. primary pci, rescue pci, pharmacoinvasive therapy. 6. connective tissue diseases.

Keywords: colchicine - pci - ppmi
anti-rheumatic drug use and risk of covid-19 infection in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis; COVID

Summary: rheumatoid arthritis (ra) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of covid-19 infection. hydroxychloroquine (hcq) has been found to possess antiviral activity against covid-19. thus, the aim of this study to investigate the ability of hcq to reduce the risk of covid-19 among ra patients.


Eligibility criteria:
inclusion criteria: - data of all definite cases of ra were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form. exclusion criteria: * the exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients. * patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke) * patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.
efficacy and safety of topical cysteamine for postinflammatory hyperpigmentation

Conditions: Hyperpigmentation; Postinflammatory

Summary: post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment. the treatment for postinflammatory hyperpigmentation is limited. recent studies have shown that the topical skin care product cysteamine cream has a significant decrease in melanin index without obvious side effects in other dark spots such as melasma. the goal of this study is to determine the safety and efficacy of topical cysteamine in the treatment of post-inflammatory hyperpigmentation.

post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment and troublesome for darker skin individuals. the current treatment with conventional bleaching cream may result in skin irritation and ochronosis that is irreversible. recent studies have shown that the topical cysteamine cream is safe and effective for dark spots such as melasma and lentigo with no significant side effects. the primary aim of this study is to evaluate the safety and efficacy of topical cysteamine for postinflammatory hyperpigmentation. we conduct a randomized control, double-blinded trial to include 40 patients with postinflammatory hyperpigmentation. clinical photography with visia skin imaging system,mexameter, transepidermal water loss, optical coherence tomography were used to evaluate the efficacy of treatment on a monthly basis for four months period. the patient was evaluated by two blinded investigator using the investigator global assessment. patient global assessment was also recorded monthly.

Eligibility criteria:
inclusion criteria: * over 20 years old * patients with postinflammatory hyperpigmentation for more than 3 months. exclusion criteria: * patients with topical hydroquinone, oral tranexamic acid and/or other skin whitening agents. * patients that receive or planning to receive laser treatment for spot removal during the study period. * individuals with allergic history to cysteamine or vehicle ingredients. * pregnant patients or patients planning to become pregnant during the time of the study.

Keywords: cysteamine postinflammatory hyperpigmentation randomized control trial double blinded
monitoring of moderate diabetic retinopathy by tele-expertise

Conditions: Diabetic Retinopathy

Summary: the aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by tele-expertise

this study compares 2 strategies of monitoring of moderate diabetic retinopathy (rd).after a consultation with an orthoptist for measurement of visual acuity, measurement of ocular tone by pulsed air tonometer, retinography pictures (9 photographs: one of the posterior pole and 8 of the retinal periphery) and optical coherence tomography (oct), results are evaluated on-site by an ophthalmologist and then sent through a secure medical online application to an ophthalmologist expert in rd for assessment. each patient is his own control.

Eligibility criteria:
inclusion criteria: * patient with complicated diabetes mellitus with moderate retinopathy exclusion criteria: * patient deprived of liberty by judicial or administrative decision * person subject to a legal protection measure * patient already involved in another clinical trial protocol

Keywords: moderate diabetic retinopathy tele-expertise
the use of a probiotic lozenge in the treatment of residual pockets after classical non-surgical therapy

Conditions: Periodontitis

Summary: the aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

the aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated. recruitment: this study will be a single centre (department of oral health sciences, university hospitals leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. the randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients. selection of the study population: adults, who consult at the department of periodontology at the university hospital leuven, and who fit the inclusion criteria will be asked to participate in this study.

Eligibility criteria:
inclusion criteria: * 40 patients * ≥ 18 years of age * scaling and rootplaning received at least 3 months ago * patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:\> 5mm or 5 and bop+ * willing and able to give written informed consent exclusion criteria: * patients with aggressive periodontitis * patients who smoke * pregnant or lactating woman * patients with poorly controlled diabetes * patients taking bisphosphonate mediation * patient who had taken systemic antibiotics 3 months prior to treatment
study of dasatinib in imatinib resistant or intolerant subjects with chronic or advanced phase cml or philadelphia chromosome positive all

Conditions: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or philadelphia chromosome positive acute lymphoblastic leukemia. the efficacy of the drug in this kind of patients will also further be documented.


Eligibility criteria:
inclusion criteria: * males and females, 18 or older * cp or ad cml or ph+ all * intolerant of resistant to imatinib * ecog ps 0-2 (cp cml) * ecog ps 0-3 (ad cml and ph+ all) * adequate hepatic and renal function exclusion criteria: * pregnant or breastfeeding females * history of significant cardiac disease * history of significant bleeding disorder (not cml)

Keywords: chronic and advanced phase cml and philadelphia chromosome positive all with imatinib intolerance or resistance
adalimumab plus methotrexate for the treatment of pediatric uveitis

Conditions: Uveitis

Summary: the aim of this study is to determine the efficacy and safety of ada plus mtx for the treatment in non-infectious pediatric panuveitis.

although non-infectious uveitis is rare in pediatric population, the irreversible visual impairment due to ocular complications, severe drug adverse effects are disturbing. there is a high rate of chronic disorder of ocular inflammation and unresponsiveness of therapy drugs in pediatric uveitis, which result in structure destruction and functional impairment including band keratopathy, posterior synechiae, cataract, and so on. the systemic and topical glucocorticoid are advocated to control inflammation but carry a high risk of lots of advert events. methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis. it was benefit to prolong remission and reduce recurrence. however, despite early intervention 27-48% children do not achieve control of inflammation and 20% experience adverse events. adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of many rheumatic diseases. ada as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis, a better visual acuity and a lower dose of dosage of daily glucocorticoid. the investigators propose to test the efficacy and safety of ada plus mtx for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of non-infectious panuveitis * age from 2 to 16 years old * vision threatening non-infectious uveitis hadn't received standardized systematic treatment before exclusion criteria: * patients who had active infection (including hepatitis b or c infection, tuberculosis), malignancy diseases, or bilateral irreversible blindness and any other contraindications of ada * previous exposure to another biologic agent

Keywords: pediatric panuveitis methotrexate adalimumab
a trial investigating the effect of nn1250 in young and elderly subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate the blood glucose lowering effect of nn1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group) * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
changes in the threshold of electrically evoked compound action potential in children following cochlear implantation

Conditions: Cochlear Hearing Loss

Summary: after cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked compound action potential (ecap).this ecap is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.

after cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked compound action potential (ecap).this ecap is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. neural response telemetry (nrt) is a quick and non-invasive way of recording ecap of the peripheral auditory nerves in-situ. it gives clinicians valuable information for programming the t- (threshold) and c-(comfort) - levels of the recipient's speech processor map. intraoperative nrt in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively.

Eligibility criteria:
inclusion criteria: * all children between 1 and 6 years of age undergoing cochlear implantation in jipmer during the study period. exclusion criteria: * incomplete electrode array insertion.

Keywords: cochlear implant threshold of electrically evoked compound action potential neural response telemetry
a study of tirzepatide (ly3298176) in participants with obesity disease

Conditions: Obesity

Summary: the main purpose of this study is to learn more about tirzepatide in participants with obesity disease. the study will also measure how tirzepatide affects body weight with a low-calorie diet and increased physical activity. the study will last around 72 weeks.


Eligibility criteria:
inclusion criteria: * have a bmi of greater than or equal to ≥27 kg/m² and \<less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. health problems are igt, hyperlipidemia, or nafld. * have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. exclusion criteria: * have diabetes. * acute or chronic liver disease other than nafld. * have a self-reported change in body weight \>5 kg within 3 months prior to screening. * have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months. * have renal impairment measured as estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2, calculated by japanese society of nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening. * have a known clinically significant gastric emptying abnormality. * have had a history of chronic or acute pancreatitis. * have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μiu/ml) at screening. * have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity. * have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years. * have a cardiovascular condition within 3 months prior to randomization * have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

Keywords: metabolism and nutrition disorder obesity related health problems obesity disease
correlation of risk factors and severity of hypoxic-ischaemic encephalopathy

Conditions: Hypoxic Ischaemic Encephalopathy

Summary: the first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in switzerland who were admitted to the neonatal and intensive care units offering hypothermia therapy. further, investigators would like to analyse the influence of these perinatal risk factors on the severity of encephalopathy during and after hypothermia therapy.

encephalopathy of the neonate could have different aetiologies. perinatal asphyxia leading to hypoxia-ischaemia is frequent ,1-2 per 1000 life born neonates are affected. hypoxic ischaemic encephalopathy is one of the most important causes for adverse neurodevelopmental outcome, cerebral palsy, epilepsy and hearing and vision deficiencies in term and near term neonates. til now, hypothermia therapy is the only therapy reducing the risk of adverse neurodevelopmental outcome and is nowadays standard of care. in this study investigators would like to analyse perinatal risk factors causing hie and their influence on the sarnat score on day 1 and 3 of life (during hypothermia therapy) and on day 4 of life (after hypothermia therapy).

Eligibility criteria:
inclusion criteria: * this study includes data of neonates suffering from hypoxic-ischaemic encephalopathy born with a gestational age \> 35 0/7 weeks, who were admitted to the neonatal and intensive care units in switzerland between 2011-2013 and were treated with therapeutic hypothermia. exclusion criteria: * neonates with hypoxic-ischaemic encephalopathy, born with a gestational age \< 35 0/7 weeks or without hypothermia treatment or syndromal diseases or with malformations were excluded. * further, children without consent to research use were excluded.

Keywords: hypothermia therapy perinatal asphyxia
topical 5-ala-pdt with blu-u therapy versus topical 5-ala with pulse dye laser in treating recalcitrant acne vulgaris

Conditions: Acne Vulgaris

Summary: the goal of this study is to compare how efficient two different types of pdts are when used in combination with topical 5-ala. the two types of pdt lights are blu-u light and candela v-beam pulse dye laser.


Eligibility criteria:
inclusion criteria: * 18-79 years of age * patients who failed the topical and oral antibiotics after 6 month therapy. * patients who failed the topical retinoids after 6 month therapy. * patients that are not good candidate to start oral isotretinoin (accutane) due to contraindications. exclusion criteria: * patients who have had isotretinoin therapy less that 1 year prior to this ala-pdt procedure. * patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures). * patients with a history of porphyria.

Keywords: acne vulgaris acne dermatalogy
accuracy of a continuous ketone monitoring (ckm) system in individuals with type 1 diabetes on insulin pump therapy.

Conditions: type1diabetes

Summary: the goal of this 14-day randomized pilot trial is to assess the accuracy of a continuous ketone monitoring (ckm) system when compared to standard point-of-care capillary ketone monitors in individuals with type 1 diabetes on insulin pump therapy. the main question it aims to answer is: - can a ckm system demonstrate equivalent ketone monitoring compared to a capillary ketone monitor with accuracy within a mean absolute difference of no more than ± 0.1 mmol/l. participants will be asked to wear the sibio ks1 ckm system for 14-days while undergoing two sequential ketogenic diets which are interspaced by an inpatient insulin-suspension period.

in this study, all study participants will wear the ckm system and collect multiple standard point-of-care capillary ketone measurements. therefore, there will be two groups in terms of measurements methods, one acting as an active comparator (the ckm system) and, the other serving as a control (point-of-care capillary ketone measurements). both groups of measurement methods will be assessed in all study participants for both the outpatient phase (sequential ketogenic diets) and, the inpatient phase (insulin-suspension period) of the study to evaluate the accuracy of the ckm system.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years of age. 2. a clinical diagnosis of type 1 diabetes (t1d) for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory c-peptide and antibodies will not be required). 3. on stable, commercial closed-loop pump therapy for the past 30 days. 4. stable use of continuous glucose monitor system for the past 30 days. 5. cellular phone with android os operating system 8.1 and above or ios11 and above operating system, for data compatibility with continuous ketone monitor mobile app (sickm app). 6. able to perform study related tasks. exclusion criteria: 1. current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (sglt2) inhibitor medication (e.g. empagliflozin). 2. current use of ascorbic acid (vitamin c) as it may impair accuracy of the sensor. 3. severe hypoglycemic episode within one month of admission, defined as an event where glucose was \<4 mmol/l resulting in seizure, loss of consciousness, needing third party assistance, or need to present to the emergency department. 4. diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month. 5. planned or ongoing pregnancy or breastfeeding individuals. 6. any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.

Keywords: continuous ketone monitoring system ketone monitoring diabetes ketoacidosis diabetes
a study of prcl-02 in healthy volunteers and plaque psoriasis

Conditions: Psoriasis

Summary: this study consists of three parts: single oral dose escalation in healthy volunteers (part a), and multiple oral dose escalations in healthy volunteers (part b) and in participants with chronic plaque psoriasis (part c)


Eligibility criteria:
inclusion criteria: parts a and b * be 18 to 55 years old * be healthy with absence of clinically significant illness * male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after * female participants must be postmenopausal or surgically sterile * have venous access sufficient for blood sampling * be a non-smoker part c * be 18 to 75 years old * have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months * have at least 2 evaluable plaques located in at least 2 body regions exclusion criteria: parts a and b * significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections * hepatic or renal impairment * hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * female participants who are pregnant or breast feeding * recent or ongoing infection * history of alcohol or drug abuse * current or recent enrollment in a clinical trial judged not compatible with this study part c * have highly active psoriatic arthritis * have pustular, erythrodermic and/or guttate forms of psoriasis * have had a clinically-significant flare of psoriasis during the last 12 weeks * currently or recently taking certain prescribed therapies for psoriasis * use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)